A Study to Investigate the Pharmacokinetic/Pharmacodynamic Characteristics of IBI128(A New Xanthine Oxidase Inhibitor)

Phase 1

Completed

• Conditions: Gout Arthritis
• Interventions: Drug: dose-5 group; Drug: dose-1 group; Drug: dose-2 group; Drug: dose-4 group; Drug: dose-3 group

• Registration Number: NCT06277752
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

A Phase I study to evaluate the pharmacokinetic/pharmacodynamic characteristics,safety and tolerability of IBI128 after multidosing in Chinese health subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-04
• Study First Submitted QC: 2024-02-19
• Study First Posted: 2024-02-26
• Status Verified: 2024-03
• Study Start: 2024-03-05
• Primary Completion: 2024-03-16
• Study Completion: 2024-03-16
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Healthy male subjects between the ages of 18 and 50 years at screening;
2. Subjects with a Body Mass Index (BMI) between 18.0 (inclusive) and 28.0 kg/m2 (inclusive); and a total body weight ≥55kg (male） and 45kg (female)
3. Participants who are overtly healthy as determined by medical evaluation including medical history, laboratory tests, vital signs and standard 12 lead ECGs.
4. Subject is willing to participate and to Sign written informed consent form.

Exclusion Criteria

1. Subjects with a history of hypersensitivities to investigational products, including drug allergies (caused by aspirin, antibiotics, etc.), or a history of clinically significant hypersensitivities
2. Subjects with evidence or a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or surgery (except simple appendectomy or repair of hernia) that may influence drug absorption
3. Subjects with evidence or a history of clinically significant hepatic (including carrier of viral hepatitis), renal, neurologic, immunologic, pulmonary, endocrine, hematological, neoplastic, cardiovascular or psychiatric (mood disorder, obsessive-compulsive disorder, etc.) diseases.
4. Subjects with a history or current have mental disease.
5. Subjects who have taken any medicine that may affect outcomes within 30 days before the first administration of the investigational product.
6. Subject who have taken IBI128 in other studies.
7. Subjects who have a history of acute arthiritis.
8. Pregnant women or breast-feeding women or men and women who has possibility of pregnancy.
9. Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IBI128	dose-3 group	IBI128 po. QD(Quaque Die)
IBI128	dose-1 group	IBI128 po. QD(Quaque Die)
IBI128	dose-5 group	IBI128 po. QD(Quaque Die)
IBI128	dose-2 group	IBI128 po. QD(Quaque Die)
IBI128	dose-4 group	IBI128 po. QD(Quaque Die)

Primary Outcome Measures

Name	Time	Method
PK parameter: AUC	Up to Day 8	Area under the concentration-time curve （AUC）of IBI128
PK parameter: Cmax	Up to Day 8	Maximum plasma concentration(Cmax) of IBI128
PK parameter: Tmax	Up to Day 8	Time to ahieve Cmax
PK parameter: T1/2	Up to Day 8	The time that takes for the dlimination processes to reduce the plasma concentration of the drug in the body by 50%.

Secondary Outcome Measures

Name	Time	Method
Tolerability parameter: SAE	Up to Day 8	Number of subjects with Serious Adverse Event
Safety parameter: AE	Up to Day 8	Number of subjects with Adverse Event
PD parameter: serum UA (uric acid）	Up to Day 8	The Percentage change of serum UA assesed by Area Under Curve 24，Cmean,24，Cmean,24 of IBI128 from baseline.

Trial Locations

Locations (1)

The First Affiliated; 🇨🇳 Zhengzhou, Henan, China